BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UREA/BUN

    MDR report key: 24935863 · Received April 21, 2026

    Report

    Report Number
    1823260-2026-01521
    Event Type
    Malfunction
    Date Received
    April 21, 2026
    Date of Event
    March 28, 2026
    Report Date
    April 21, 2026
    Manufacturer
    ROCHE DIAGNOSTICS
    Product Code
    CDQ
    UDI-DI
    07613336121603
    PMA / PMN Number
    K972250
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ANALYZER SERIAL NUMBER IS (B)(6). THE FIELD SERVICE ENGINEER (FSE) CHECKED AND ADJUSTED THE CELL FILLING VOLUMES, ADJUSTED THE WASH STATION, AND REPLACED THE WASH STATION TUBING AND TEFLON FITTINGS ON THE PHOTOMETRIC UNIT. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 0

    THERE WAS AN ALLEGATION OF QUESTIONABLE UREA/BUN RESULTS FOR 1 PATIENT SAMPLE ON A COBAS C 703 ANALYTICAL UNIT. THE INITIAL RESULT WAS 0.819 MMOL/L. THE CUSTOMER QUESTIONED THE RESULT AS IT DID NOT MATCH THE PATIENT'S PREVIOUS RESULT. THE REPEAT RESULT WAS 12.7 MMOL/L. THE REPEAT RESULT WAS DEEMED CORRECT. NO QUESTIONABLE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    996307 UREA/BUN UREA NITROGEN TEST SYSTEM CDQ ROCHE DIAGNOSTICS 94454001 07613336121603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown